Clinical trial · Interventional
Predicting Neoadjuvant Therapy Response of Rectal Cancer With MRI
NCT02640586CI-TRIAL-00067401unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to investigate if MRI scans performed after neoadjuvant radiotherapy can predict the therapeutic response of rectal cancer following preoperative chemo-radiotherapy. This will help doctors to better tailor treatments for rectal cancer in the future.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| three MR examination | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Assessing response with MRI
- description
- Preoperative chemo-radiotherapy as standard treatment. Neoadjuvant therapy (long course intensity modulated radio-chemotherapy, GTV 50.6Gy, totally 22 fractions; Capecitabine 825mg/m2 /bid by oral administration). Three MR examinations: first MRI taken within 1 week before preoperative chemo-radiotherapy; second MRI taken between 14-16days after the initiation of radio-chemotherapy; third MRI taken 7-9 weeks after the completion of preoperative chemo-radiotherapy. All patients are scheduled to receive total mesorectal excision surgery 12-14 weeks after the completion of preoperative chemo-radiotherapy.
- interventionNames
- Device: three MR examination
Primary outcomes (2)
- measure
- Predictive value of eary MRI (14-16 days MRI) for assessing pathological complete response(pCR) at surgery
- timeFrame
- 2 years
- description
- A scoring system for predicting pCR will be developed based on MRI parameters and their changes between baseline and early MRI. No viable cancer cells seen in the resection specimen is regarded as pCR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 years * T3/4 or node positive biopsy-proved primary rectal cancer * Suitable for pre-operative chemoradiotherapy and surgical resection * No contraindication to MRI * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * History or concurrent of other cancer * Previous therapy to pelvis * Unable/unwilling to have MRI * Pacemaker or implanted defibrillator * Pregnancy, lactation or inadequate contraception * Patients with a history of psychological illness or condition such as to interfere with the patient's ability to understand requirements of the study * Unwilling or unable to give informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.